MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PHASIX MESH; SURGICAL MESH

Catalog Number	1190400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Obstruction/Occlusion (2422)
Date of Event	06/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided at this time, no conclusion can be made as to the degree to which the mesh implant used to treat the patient may have caused or contributed to the patient's current symptoms.It appears that there is a cascade of medical issues related to the identified hernia recurrence.Recurrence is a known inherent risk of hernia repair surgery.The adverse reaction section of the instructions-for-use identifies recurrence as a possible complication, additionally the warning section states, "to prevent recurrences when repairing hernias, the phasix¿ mesh must be large enough to provide sufficient overlap beyond the margins of the defect.Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue." a review of the manufacturing records showed no issues associated to the reported event.All process steps were completed per manufacturing and inspection procedures.Product passed all required inspections at each step at end product level.There was no manufacturing abnormalities noted.Should additional information be provided, a supplemental mdr will be submitted.Note: the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.Remains implanted.
Event or Problem Description
Event was reported via post market clinical study.On (b)(6) 2016 the patient underwent the repair of an infraumbilical hernia with 2 stomas present.An endoscopic retro-rectus with component separation technique and removal of excess skin were performed.The wound and fascia were closed with absorbable suture.The skin was fully closed.On (b)(6) 2017 during a follow up visit the patient was noted to have a normal scar, small peristomal hernia (assessed by the clinician as not related to the device and not related to the procedure) at simoideostomy, and a normal urosotmy.The patient experienced daily vomiting and abdominal colic pain from mid (b)(6) 2018.It is noted that the vomiting might be caused by adhesions as a result of surgery.On (b)(6) 2018 the patient was diagnosed with a recurrence of the incisional hernia.The event is assessed by the clinician as ongoing, severe and possibly related to the device.The event is assessed by the clinician as definitely related to the procedure.On (b)(6) 2018 the patient had become severely dehydrated and was admitted to her local hospital for evaluation and re-hydration.She was discharged (b)(6) 2018 with a referral for further evaluation and treatment.On (b)(6) 2018 the patient was seen at outpatient clinic where a gastroscopy and ct was prescribed.Gastroscopy was performed (b)(6) 2018 and was inconclusive.Ct was also performed and was evaluated at conference (b)(6) 2018.The ct revealed a recurrence of the incisional hernia resulting in partial obstruction of the small bowel.The patient is awaiting surgery to take place to repair the hernia.
Event or Problem Description
Event was reported via post market clinical study.On (b)(6) 2016 the patient underwent the repair of an infraumbilical hernia with 2 stomas present and was implanted with a davol phasix mesh.An endoscopic retro-rectus with component separation technique and removal of excess skin were performed.The wound and fascia were closed with absorbable suture.The skin was fully closed.On (b)(6) 2017 during a follow up visit the patient was noted to to have a normal scar, small peristomal hernia (assessed by the clinician as not related to the device and not related to the procedure) at simoideostomy, and a normal urosotmy.The patient experienced daily vomiting and abdominal colic pain from mid april 2018.It is noted that the vomiting might be caused by adhesions as a result of surgery.On 04/15/2018 the patient was diagnosed with a recurrence of the incisional hernia.The event is assessed by the clinician as ongoing, severe and possibly related to the device.The event is assessed by the clinician as definitely related to the procedure.On (b)(6) 2018 the patient had become severely dehydrated and was admitted to her local hospital for evaluation and re-hydration.She was discharged 05/10/2018 with a referral for further evaluation and treatment.On (b)(6) 2018 the patient was seen at outpatient clinic where a gastroscopy and ct was prescribed.Gastroscopy was performed (b)(6) 2018 and was inconclusive.Ct was also performed and was evaluated at conference (b)(6) 2018.The ct revealed a recurrence of the incisional hernia resulting in partial obstruction of the small bowel.The patient is awaiting surgery to take place to repair the hernia.Addendum to document additional procedure.On (b)(6) 2018 the patient underwent repair of the recurrent hernia.Two hernia defects were identified and an 11cm x 14cm davol ventrio mesh was placed and secured with suture and mechanical fixation.There was no residual material of the previously inserted phasix mesh, which is resorbable.The patient's recovery was uncomplicated.
Additional Manufacturer Narrative
This is an addendum to the initial emdr to document repair of the recurrent hernia.As reported there was no residual material from the previously placed phasix mesh seen during the revision procedure.Phasix mesh is a fully resorbable mesh.Absorption of the mesh material is essentially complete within 12 to 18 months.The revision procedure was approximately 19 months post implant.The initial determination remains unchanged.Based on the information provided at this time, no conclusion can be made as to the degree to which the mesh implant used to treat the patient may have caused or contributed to the patient's symptoms.It appears that there is a cascade of medical issues related to the identified hernia recurrence.A review of the manufacturing records showed no issues associated to the reported event.All process steps were completed per manufacturing and inspection procedures.Product passed all required inspections at each step at end product level.There was no manufacturing abnormalities noted.Recurrence is a known inherent risk of hernia repair surgery.The adverse reaction section of the instructions-for-use identifies recurrence as a possible complication, additionally the warning section states, "to prevent recurrences when repairing hernias, the phasix¿ mesh must be large enough to provide sufficient overlap beyond the margins of the defect.Careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue." should additional information be provided, a supplemental mdr will be submitted.

• Brand Name: PHASIX MESH
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7616109
• Report Number: 1213643-2018-02047
• Device Sequence Number: 19406199
• Product Code: OOD
• UDI-Device Identifier: 00801741077692
• UDI-Public: (01)00801741077692
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142818
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: foreign,other,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2017
• Device Catalogue Number: 1190400
• Device Lot Number: HUZJ1532
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 06/21/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 52